Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, has announced that the FDA has approved IMMGOLIS (golimumab‑sldi) and IMMGOLIS INTRI (golimumab‑sldi), the first biosimilar versions of golimumab reference products Simponi and Simponi Aria. IMMGOLIS is approved for the treatment of adults with moderately to severely active rheumatoid arthritis in combination with methotrexate, as well as adults with moderately to severely active ulcerative colitis. IMMGOLIS INTRI is approved for adults with moderately to severely active rheumatoid arthritis, also in combination with methotrexate. All four products—Simponi, Simponi Aria, IMMGOLIS and IMMGOLIS INTRI—carry a boxed warning for serious infections and malignancy, and the company directs prescribers to the full boxed warnings in the prescribing information.
IMMGOLIS and IMMGOLIS INTRI are the first FDA‑approved golimumab biosimilars and will be commercialized exclusively in the United States by Accord BioPharma. Both agents have been designated interchangeable with their reference products for rheumatoid arthritis and ulcerative colitis, opening the door to substitution at the pharmacy level in accordance with state law. According to the company, this marks the first time patients with rheumatoid arthritis and ulcerative colitis in the U.S. will have an FDA‑approved biosimilar option for both Simponi and Simponi Aria, which Accord describes as a pivotal step toward broader access to biologic therapy. The products are expected to be available to patients and providers in the fourth quarter of 2026.
“As the first golimumab biosimilars approved in the U.S., IMMGOLIS and IMMGOLIS INTRI represent a meaningful new option for people in the U.S. who are living with the chronic, debilitating autoimmune conditions associated with moderately to severely active rheumatoid arthritis or ulcerative colitis and need more affordable medication,” said Chrys Kokino, president of Accord North America. He added that the approval responds to clear demand in the U.S. market and supports the company’s goal of bringing 20 biosimilars to market by 2030.
Binish Chudgar, chairman and managing director of Intas Pharmaceuticals, called biosimilars “one of the most powerful tools” for improving affordability and access across the U.S. healthcare system. He said Accord BioPharma’s “deep expertise, dedicated team, and bold vision” position it well to introduce this first‑of‑its‑kind golimumab biosimilar offering to U.S. patients and providers later this year. IMMGOLIS and IMMGOLIS INTRI were developed by Bio‑Thera Solutions, which will continue to oversee manufacturing and product supply while Accord BioPharma leads U.S. commercialization.
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